Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT02288156
Eligibility Criteria:
Inclusion Criteria:
* idiopathic rhinitis patients with at least 2 persistent (\> 12w) rhinological symptoms (nasal discharge, sneezing, nasal congestion) for an average of at least 1 h per day,
* idiopathic rhinitis patients with a total nasal symptoms score (TNS) of 5 or more on a visual analogue scale (VAS).
* Age \> 18 and \< 65 years.
* Written informed consent.
* Willingness to adhere to visit schedules.
* Adequate contraceptive precautions in female patients with childbearing potential.
Exclusion Criteria:
* Patients with concomitant allergic rhinitis, demonstrated by positive skin prick test (Hal reagents) and/or immunoglobins E in blood. \*
* Patients with structural abnormalities: nasal polyps, severe septal deviation (septum reaching concha inferior or lateral nasal wall), septal perforation, hypertrophy of the inferior turbinates.
* Patients with local allergic rhinitis (LAR) or entopy.
* Systemic steroid treatment less than 4 weeks before the inclusion in the study, nasal steroid spray less than 4 weeks before the inclusion, oral leukotriene antagonists or long-acting antihistamines less than 2 weeks before the inclusion.
* Inability of the patient to stop taking medication affecting nasal function like ß-blockers.
* History of prolonged use or abuse of decongestant nasal spray like xylometazoline spray and/or use or abuse of decongestive oral medication.
* Evidence of infectious rhinitis/rhinosinusitis or common cold within 4 weeks prior to inclusion.
* Pregnancy or lactation. \*\*
* Any disorder of which might compromise the ability of a patient to give truly informed consent for participation in this study.
* Enrollment in other investigational drug trial(s) or receiving other investigational agent(s) for any other medical condition.
* Contra-indications for the use of local anesthesia (cocaine 5%).
* Smoking or occupational exposure to irritants (like hypochlorite, persulfates, isocyanates).
* Nasal malignancies or severe comorbidity like granulomatosis or vasculitis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02288156
Study Brief:
Protocol Section:
NCT02288156